Validation and Qualification Specialist

Flexible & Integrated Technical Services, LLC • Guayama, PR

3d • Onsite

About The Position

For Validation & Qualification services in the Manufacturing and Engineering area. We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!

Requirements

• Bachelor’s Degree in Life Sciences or Engineering
• Previous exposure to Validation and/or Qualification activities within the pharmaceutical and medical devices industry.
• Bilingual: (Spanish and English)
• Validation principles, protocols, and lifecycle management
• Manufacturing and packaging equipment.
• GMP & GDP regulations

Nice To Haves

• Treats everyone they meet like family, especially our resources, clients and team members.
• Customer service skills.
• Innovative and eager to innovate.
• Delivers top-quality results.

Responsibilities

• Execute and manage the qualification lifecycle for equipment and processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Develop, review, and execute validation protocols and reports in accordance with GMP and company standards.
• Generate and maintain change control documentation for equipment and process modifications.
• Perform troubleshooting and root cause analysis for validation-related issues.
• Ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements throughout all validation activities.
• Collaborate with manufacturing, packaging, and quality teams to support equipment qualification and process improvements.
• Maintain accurate and timely documentation in alignment with internal SOPs and regulatory expectations.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level